HEMARTY Hemorrhoid Artery Minimalisation A Randomized Trial of a ligation Therapy (Doppler guided HAL versus non-doppler guided HAL procedure)

Completed

• Conditions: piles; 10002112

• Registration Number: NL-OMON30975
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Age above 18 years
Complains for more than 3 months of haemorrhoid related complains
Haemorrhoid Grade 2 resistant to rubber band ligation
Haemorrhoid Grade 3
ASA 1 and 2

Exclusion Criteria

Previous gastro-intestinal malignancy
Previous surgery in the rectum including treatment for haemorrhoids within the last 10 years.
Simultaneously presence of other anal disorders, such as anal fissure, fistula, abscess, colon/anus carcinoma
Unable to understand instructions (eg. Language barrier)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cost effectiveness analyses of the artery ligations procedures. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To establish the reduction of anal blood flow (decrease of vessel diameter) in<br /><br>both groups as measured with intra anal Duplex before and after the procedure.<br /><br>Next to the changes in rectal compliance in both groups as measured with anal<br /><br>manometry before and after the procedure.<br /><br>Other secondary parameter/endpoints involve the next items<br /><br>• The duration of the procedure<br /><br>• Post operative complications (VAS score)<br /><br>• Post operative pain </p><br>